Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
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- Who are Economic Operators?4
- 1.1Economic Operators (EOs): Manufacturer, Authorized Representative, Importer, Distributor.
- 1.2Scope under EU MDR 2017/745 & IVDR 2017/746.
- 1.3UDI, CE marking, PMS (Post-Market Surveillance), Vigilance, EUDAMED, GDP (Good Distribution Practice).
- 1.4Distinction between legal liability vs operational responsibility.
- Importer & Distributor Obligations5
- 2.1Importer Obligations: Product Conformity Check & UDI/EUDAMED Registration
- 2.2Importer Obligations: Storage & Handling, Complaint Handling, Cooperation With Competent Authorities.
- 2.3Distributor Obligations: Verification Of CE Marking, Labeling & IFU, Traceability, Complaint Forwarding, Corrective Actions.
- 2.4Global context: FDA (US supply chain requirements), MHRA (UK), WHO GDP standards.
- 2.5Risks of non-compliance: Recalls, Fines, Supply Chain Disruption, Brand Damage.
- Real-Life Case Sharing – Lessons from Enforcement4
- 3.1Case 1: Importer penalized for marketing non-conforming IVD kits in EU.
- 3.2Case 2: Distributor recall due to improper storage & temperature excursions.
- 3.3Case 3: Market disruption caused by incomplete EUDAMED registrations.
- 3.4Case 4: Successful compliance system by a multinational distributor using digital track & trace.
- Interactive Exercises & Simulation3
- 4.1Simulation: Teams analyze a scenario where an importer fails to verify CE marking and identify corrective actions.
- 4.2Group Exercise: Draft an obligations checklist for importers and distributors in line with MDR/IVDR.
- 4.3Role-Play: Regulatory authority inspection → importer/distributor teams must respond with documentation & compliance evidence.
- Wrap-Up & Key Takeaways4
- 5.1Importers and distributors are no longer passive players; they carry legal accountability.
- 5.2Compliance requires traceability systems, proactive verification, and PMS integration.
- 5.3Audit readiness and clear SOPs reduce regulatory risks.
- 5.4Collaboration across manufacturers, ARs, importers, distributors is key to seamless market access.